GALT News & Events

Galectin Therapeutics announced that the U.S. Food and Drug Administration, FDA, has provided a written response, and subsequent communications, to the Company's previously submitted Type C meeting request regarding the development program for belapectin, its investigational galectin-3 inhibitor. The FDA converted the Company's initial request for an in-person or teleconference meeting to a written response. Based on FDA's written feedback, the Company believes there is alignment with the Agency on the patient population proposed for enrollment in a registration trial. In addition, Galectin Therapeutics had previously reached an agreement with the FDA on the use of a centralized, blinded endoscopy review for esophageal variceal assessment and plans to apply a similar approach for variceal evaluation in its next study.

"The new NAVIGATE data presented at AASLD further strengthen the clinical and mechanistic profile of belapectin. We continue to see encouraging consistency across key biomarkers-including FibroScan, ELF, and PRO-C3-all supporting belapectin's durable antifibrotic activity and potential to slow disease progression in patients with compensated MASH cirrhosis. We submitted the NAVIGATE data package to the FDA and requested feedback on proposed next steps, with guidance anticipated by year-end. As we move forward, our focus remains on advancing dialogue with FDA and exploring strategic opportunities to maximize the value of this promising program," said Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics.

Galectin Therapeutics presented a poster and will deliver an oral presentation of the NAVIGATE study analysis at the American Association for the Study of Liver Diseases, AASLD, 2025 Annual Meeting. The Phase 2 NAVIGATE trial evaluated belapectin, a proprietary galectin-3 inhibitor, in patients with compensated MASH cirrhosis and portal hypertension. The global Phase 2b NAVIGATE trial was a randomized, double-blind, placebo-controlled study evaluating the galectin-3 inhibitor belapectin in 355 patients with compensated MASH cirrhosis and portal hypertension confirmed by non-invasive markers and baseline endoscopy. Patients were randomized 1:1:1 to receive intravenous belapectin at 2 mg/kg or 4 mg/kg of lean body mass or placebo every other week for 18 months. When patients were stratified using FDA-approved Enhanced Liver Fibrosis score cutoffs, belapectin 2 mg/kg demonstrated a consistently lower incidence of new varices across all fibrosis categories, with the largest reduction observed among patients with ELF greater than11.3, representing those at highest risk for liver complications.